July 11, 2014 — Hospira has issued a voluntary recall of one lot of Lactated Ringer’s and 5% Dextrose injection after receiving one customer report of visible particulate in the solution.
Recalled products include:
- Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09, Lot 35-118-JT, Expiration November 1, 2015.
The particulate matter was identified as a filamentous-like structure indicative of mold. Further investigation of the container and overwrap discovered a puncture in the same physical location, causing the primary container to leak.
The sterility of leaky containers cannot be guaranteed. If the leak is not discovered, it is possible that contaminated solution could cause a hospital infection.
According to the warning:
“Intravenous administration of a non-sterile product can result in infections that may be life-threatening, and may result in prolonged hospitalization or organ failure. Hospira has not received reports of any adverse events associated with this issue for this lot to date.”
Hospira has already implemented corrective action to address the issue. They did not find any quality problems with samples that were retained from the affected lot.
The recalled products are used to replace fluids and electrolytes, with or without carbohydrate calories, depending on the patient. It is packaged in 1000mL flexible containers. Products were sold to hospitals, clinics, and distributors between December 2013 and February 2014.
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